Bioequivalence and Bioavailability Forum

Drar Ohlbe,

❝ My understanding was that "guideline" was preferred to "Note for guidance" because it is the wording used in Annex I to Directive 2001/83/EC. Nothing more.

And furthermore (no pun intended), the CHMP rules of procedure allow CHMP to make "guidelines" through the working parties and drafting groups. Nothing more....well.... except "proposals"

Anyone confused? With good reason. Directive 2001/83 on occasion mentions compliance with guidelines as well as principles. Principles and guidelines or their differences aren't really defined further (neither are they in the EMA regulation from the commission) But perhaps we need to distinguish between principles and guidelines since 2001/83 does not make use of the terms interchangeably?!? In that case ICH E6 is not a guideline, because the directive speaks of the principles of god clinical practice. And so on and so forth.

We should make a list of terms that we'd like to see defined for practical use. On top of my list are the dreadful "pre-clinical tests and clinical trials" from article 10.3.